Prosthetic implant delivery device and method

ABSTRACT

A prosthetic implant transfer device is provided that may be used to insert a prosthetic implant through a surgical opening. In some embodiments, the device may comprise a flexible sheet of material that may be formed into an elongated hollow structure. The flexible sheet of material includes a plurality of fasteners that may be selected and engaged to define a desired size distal opening.

RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 16/144,617, filed on Sep. 27, 2018; which is a continuation ofU.S. Pat. No. 10,105,213, issued on Oct. 23, 2018, the disclosures ofwhich are incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This invention is directed to a delivery apparatus for facilitating theinsertion of a prosthesis, such as a breast implant, into a surgicalpocket, and method for using the device.

BACKGROUND OF THE INVENTION

This invention relates to the placement of prosthetic implants within apatient's body. Prosthetic implants, such as breast implants, pectoralimplants, gluteal implants, and others have been used extensively formany years. Prosthetic implants can take many forms, many of which arecomprised of a compressible or deformable material, such as silicone. Inorder to place such an implant within a body or a cavity of a patient,an incision is made to access the desired site of placement and developthe pocket or space between the tissue planes where the implant willreside.

It is desirable that the incision in the patient for the surgical pocketbe as small as possible for a variety of reasons including, reducedtrauma to the patient, shorter recovery time, and lessened infectionrisk. The incision is therefore smaller than the implant itself. Inorder to insert the implant through the incision, a surgeon willmanipulate the implant by hand to deform or compress it and guide itthrough the incision into the surgical pocket. Such direct handling ofthe implant has several shortcomings.

The time involved in manipulating the implant to guide it through therelatively small incision is greater than with a large incision. Thisadditional surgical time increases the risks of infection andcomplications from anesthesia. The amount of time required also impactsthe costs of the procedure because of the additional time of thephysician and staff. In some instances, implant failures in the form ofminor damage to the outer surface of the implant can also be caused bythe manipulation.

In order to address these problems, one device that has been developedis a flexible tapered funnel to aid in sliding a breast implant throughthe incision. U.S. Pat. No. 8,211,173 issued to Keller et al. disclosesan apparatus and process for delivering a silicone breast implant into asurgical pocket. U.S. Pat. No. 8,211,173 discloses a tapered sleevehaving a wider first end for receiving a breast implant, and a smallersecond end for insertion into the surgical pocket. By placing the breastimplant in the sleeve, a surgeon squeezes the sleeve to deform thebreast implant and force it through the second end and into the surgicalcavity. In order to accommodate different size implants, the second endof the sleeve is trimmed to create the desired size hole. Transferringof the implant through the sleeve is aided by lubrication of the implantand/or interior surface of the sleeve itself.

While the flexible funnel has provided some advantages, the presentinvention addresses certain shortcomings to the funnel. Becauseadjustment of the opening through which the implant is squeezed is doneby way of cutting a portion of the end of the sleeve, an error in sizingmay result in having to discard the funnel and trim a new one, which canadd to the cost of the procedure. Another problem that has beenencountered with the funnel results when the force applied to theoutside of the funnel to squeeze the implant sufficiently actuallydamages the implant. In addition to traumatizing the surgical site, thedamaged implant cannot be used, which again increases costs. Anotherproblem that has been experienced results when the force required totransfer the implant through the end of the sleeve causes the sleeveitself to burst at a seam. In some instances, the sleeve may fail due toa tear or inadvertent cut at the end of the sleeve accidentally madewhen the sleeve is trimmed. Although not common, another issue that mayoccur stems from the open proximal end that receives the implant.Because of the substantial lubrication that is utilized to allow theimplant to be transferred through the distal end, possible mishandlingof the funnel may result in the implant sliding out of the proximal openend.

The present invention seeks to address these shortcomings and provide animproved device.

SUMMARY OF THE INVENTION

The present invention is directed to a delivery system for inserting aprosthetic implant through a surgical opening. In some embodiments, thesystem comprises a flexible sheet of material defining a first sideportion and a second side portion. Formed with either the first sideportion or the second side portion, or both of the first and the secondside portions are a plurality of fasteners. The fasteners are adapted tosecure the first side portion with the second side portion to form anelongated hollow form that defines a distal opening. In that there are aplurality of fasteners, a surgeon can select desired fasteners so that adesired size of the distal opening is determined by way of theparticular fasteners that are used. For example, fasteners towards theedges of the first and second side portions will, when the first andsecond side portions are secured with one another, define a relativelylarge distal opening. By contrast, fasteners spaced from the edge of thefirst or second side portions will, when the first and second sideportions are secured with one another, define a smaller distal opening.In a preferred embodiment, the orientation of the fasteners will, whenthe first and second edge portions are secured to one another result ina hollow, open-ended frustoconical form. In other embodiments, theorientation of the fasteners will, when the first and second edgeportions are secured to one another result in a hollow, open-endedcylindrical form.

In yet other embodiments, the sheet of material may be configured suchthat when the fasteners are engaged, a hollow elongated form that isenclosed except for one open distal end is assembled. As with theprevious embodiments, in this embodiment the size of the opening at thedistal end is determined by the particular fasteners that are selected.

In yet another embodiment, material is pre-formed as a hollow elongatedform that is enclosed except for the distal end portion. The distal endportion defines a first side portion and a second side portion. Formedwith either the first side portion or the second side portion, or bothof the first and the second side portions are a plurality of fasteners.The fasteners are adapted to secure the first side portion with thesecond side portion to define a distal opening. In that there are aplurality of fasteners, a surgeon can select desired fasteners so that adesired size of the distal opening is determined by way of theparticular fasteners that are used.

In the various embodiments, the material may take on different forms. Inone embodiment, the material is a thin flexible transparent plastic orother polymer material, which may be transparent or semi-transparent. Inother embodiments, a mesh material, and preferably a graded meshmaterial, is utilized. With respect to the graded mesh material, it ispreferred that in an assembled form, the distal portion of the materialis less expandable than the more proximal portions. In so doing, thesurgeon transfers the implant towards the distal end through portions ofdecreasing expansibility.

It is preferred that a lubricant be utilized to aid in transferring theimplant through the distal end. The particular lubricant can be providedseparately from the system or may be integral with the system. Thelubricant may be liquid lubricant or may be a dry lubricant. Thelubricant may be ready-to-use, or may require activation, such as by awetting agent.

The plurality of fasteners may also take several forms. For example,formed with the first side portion may be a connection channel, whilethe second side may have formed therewith connection zippers, tabs orhooks adapted to be received within the connection channel and besecured therewith. Alternatively, the first side portion may define tabsand the second side portion may define slots adapted to receive the tabsso as to be secured therein.

Although not part of the claimed invention, it should be understood thatthe present invention may be used with a variety of prosthetic implants.While silicone gel implants such as breast implants are one type ofcontemplated implant, other implants may be made of solid deformablesilicone, such as pectoral or gluteal implants. In addition tosilicone-based implants, prosthetics made of other deformable orcompressible materials may be used.

These and other features, aspects, and advantages of the presentinvention will become better understood with reference to the followingdescription and appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A fully enabling disclosure of the present invention, including the bestmode thereof to one of ordinary skill in the art, is set forth moreparticularly in the remainder of the specification, including referenceto the accompanying drawings.

FIG. 1 is a perspective view of a preferred embodiment of the presentinvention in an unassembled condition;

FIG. 2 is a perspective view of the embodiment of FIG. 1 in an assembledcondition;

FIG. 3 is a perspective view of the embodiment of FIG. 1 during possibleuse;

FIG. 4 is a perspective view of an alternative preferred embodiment ofthe present invention in an unassembled condition;

FIG. 5 is a perspective view of the embodiment of FIG. 4 in an assembledcondition;

FIG. 6 is a perspective view of another alternative preferred embodimentof the present invention in an unassembled condition;

FIG. 6A is a perspective view of another alternative preferredembodiment of the present invention in an unassembled condition;

FIG. 6B is a perspective view of the embodiment of FIG. 6A, with animplant;

FIG. 6C is a perspective view of the preferred embodiment as shown inFIG. 6A and FIG. 6B in an assembled condition;

FIG. 6D is a perspective view of the preferred embodiment as shown inFIG. 6A and FIG. 6B in use;

FIG. 7 is a perspective view of another alternative preferred embodimentof the present invention in an unassembled condition;

FIG. 8 is a perspective view of another alternative preferred embodimentof the present invention in an unassembled condition;

FIG. 9 is a perspective view of another alternative preferred embodimentof the present invention in an unassembled condition; and

FIG. 10 is a perspective view of another alternative preferredembodiment of the present invention in an unassembled condition.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to preferred embodiments of theinvention, one or more examples of which are set forth below. Eachexample is provided by way of explanation of the invention, notlimitation of the invention. It will be apparent to those skilled in theart that various modifications and variations can be made in the presentinvention without departing from the scope or spirit of the invention.For instance, features illustrated or described as part of oneembodiment can be used on another embodiment to yield a still furtherembodiment. Thus, it is intended that the present invention cover suchmodifications and variations as come within the scope of the appendedclaims and their equivalents. Other objects, features, and aspects ofthe present invention are disclosed in the following detaileddescription. It is to be understood by one of ordinary skill in the artthat the present discussion is a description of exemplary embodimentsonly and is not intended as limiting the broader aspects of the presentinvention, which broader aspects are embodied in the exemplaryconstructions.

Referring to FIG. 1 , a preferred embodiment of the present invention isdepicted in an unassembled form, which is the form in which the deviceis intended to be provided to users. As shown, prosthetic implant device10 comprises a sheet of material 12 defining a proximal end 14 and thedistal end 16. In this preferred embodiment, formed with a first sideportion 18 are a plurality of first fasteners in the form of channels20, and formed with a second side portion 22 is a second fastener in theform of shoulder 24. The shoulder and channels are configured to bemated to one another in a zip-type manner. Such zip-type fasteners areknown in the art, and may comprise a channel in the form of a groove orseries of hooks that are adapted to engage the shoulder, which may begenerally shaped with arrowhead-like, mushroom shaped cross-section,omega-shaped cross-sectional outline, or the like. Other zip-typeengagements may also be utilized. A tab, such as tab 26 may be included.Tab 26 is depicted in schematic form, and is not intended to providespecific details on the zipping operation in that the particular zippersthat may be used will be understood by persons of skill in the art.Whether the first fasteners define the groove and the second fastenerdefine the shoulder or vice-versa is a matter of design choice. Itshould also be understood that the term fastener may denote one part ofcooperating structures that act to fasten other structures to oneanother, such as the groove and shoulder portions of a zip-typefastener.

The flexible sheet further defines a first edge 28 and a second edge 30that is transverse from the first edge 28. Each of the first fasteners20 is either integrally formed with the sheet 12 or may be fixedthereto. The first fasteners 20 are disposed in a generally longitudinalrelationship with the first edge 28. In this embodiment, each of thefirst fasteners 20 defines a proximal end 32 and a distal end 34.Similarly, the second fastener defines a proximal end 36 and a distalend 38. The first fasteners 20 are preferably in parallel relationshipto one another. The proximal end 32 for each first fastener 20 ispositioned a first distance, such as distance A, from the proximal end36 of the second fastener 24. The distal end 34 of the first fastener 20is a second distance, such as distance B, from the distal end 38 of thesecond fastener 24, and the first distance is greater than the seconddistance.

Referring to FIG. 2 , prosthetic implant device 10 is depicted in anassembled form. In order to assemble prosthetic implant device 10, asurgeon determines a desired size for a distal opening of the assembledinsertion device by evaluating the size of the prosthetic implant thatwill be transferred through the insertion device. The size of the distalopening of the assembled insertion device can vary based both on theimplant size and incision size although more commonly it varies based onthe implant size as the incision size for a given procedure, whiledependent on surgeon preference, does not vary significantly. Thesurgeon then selects first fastener from the plurality of firstfasteners 20 and engages the second fastener 24 with the selected firstfastener. Depending on which first fastener is selected, the resultingdistal opening 40 of the formed prosthetic implant device will be largeror smaller. As should be apparent, one of either the plurality of firstfasteners 20 or the second fastener 24 should be one an outside surfaceof the sheet and the other on the inside surface of the sheet. Whenassembled, the fasteners are not exposed on the interior of the device,and therefore will not contact and potentially damage the implant. Asshown, the assembled apparatus includes a seam 42. If desired, asupplemental second fastener can be included. If such a supplementalsecond fastener is included, it is preferable that the spacing betweenthe first fasteners and the spacing between the second fastener andsupplemental second fastener are equal so that the supplemental secondfastener may engage one of the first fasteners while the second fastenerengages a different first fastener. It should also be appreciated thatwhile the fasteners in the embodiments shown are linear, they may becurved so as to create desired shapes from the sheet of material.

Referring to FIG. 3 , a prosthetic implant 44 is placed within theformed prosthetic implant device 10. The surgeon applies a force to theproximal end 14 of the device 10 to transfer the implant 44 distallythrough the distal opening 40, and through incision 46. The distal endof the device 10 is typically inserted 5-10 mm within the incision 46 asthe implant 44 is transferred through the incision 46 into the pocketthat had been created by the surgeon to receive it. In this particularexample, the incision is made in the inframammary fold beneath thebreast, however, the incision may also be made through any incision,such as transaxillary and periareolar. This ensures “touchless” anduninterrupted passage and transfer of the implant 44 through the implantdevice 10 into the surgical pocket while minimizing risk of inadvertentexternal delivery of the implant 44 or direct contact of the implant 44with the skin.

Sheet 10 is made of a thin sheet of flexible material. In someembodiments, the material may be pliable, yet substantiallyinextensible. It is also preferred that the material be translucent ortransparent. Various material that may be suitable include Mylar®,plastics made from Tygon® brand of plastics, vinyls, polyvinyl chloride,and other similar materials. The material must also be able to besterilized by way of conventional sterilization techniques. There arenumerous materials that may be suitable, as will be understood bypersons skilled in the art. For example some suitable materials aredisclosed in the aforementioned U.S. Pat. No. 8,211,173, and thedisclosure of such materials are incorporated herein by reference.

In other embodiments, the sheet of material may be a mesh. Referring toFIG. 4 , a second preferred embodiment of a prosthetic implant device110 is disclosed. In this embodiment, the sheet of material 112 isformed of a graded mesh. The sheet 112 defines a proximal end 114 adistal end 116. In this embodiment, formed with a first side portion 118are a plurality of first fasteners in the form of channels 120, andformed with a second side portion 122 is a second fastener in the formof shoulder 124, similar to the previous embodiment.

The flexible sheet 110 further defines a first edge 128 and a secondedge 130 that is transverse from the first edge 128. The first fasteners120 are disposed in a generally longitudinal relationship with the firstedge 28. In this embodiment, each of the first fasteners 20 is alignedgenerally parallel to the first edge. Similarly, the second fastener 124is aligned generally parallel to the second edge 130.

In a preferred form, the sheet of material 112 is a graded mesh thatprovides greater expandability towards the proximal end 114, and becomeless expandable towards the distal end 116. The distal end 116 isconfigured such that it provide sufficient resistance to expansion suchthat it will cause the implant to deform or compress as it transferredthrough the distal end. Because the proximal end 114 of the material 112is expandable, the assembled device need not go from a larger proximalopening to a smaller distal opening. Rather, the device 110 may becylindrical when assembled as shown in FIG. 5 . As depicted, the implant144 is located within an expanded portion of the proximal end 114 of thedevice 110. The implant can be inserted through the proximal end, or maybe laid on the sheet of material and then the fasteners engaged.

By providing means for adjusting the size of the distal opening by wayof fasteners, in some embodiments, one may insert the implant into thedevice through the distal end. Referring to FIG. 6 , an embodiment thatallows for the implant to be placed into the device by way of a distalopening is described. Prosthetic implant device 210 comprises a flexibleelongated member 211 defining a proximal end portion 214 that is shownas a cylindrical form. The distal end portion 216 defines a firstlongitudinal edge 218 and a second longitudinal edge 220. These firstand second longitudinal edges define a longitudinal opening 222. Aplurality of first fasteners 224 are formed longitudinally adjacent thelongitudinal edge 218 on a first portion 226. A second fastener 228 isformed longitudinally adjacent the second longitudinal edge 220 on asecond portion 230. Since in this embodiment the first fasteners arelocated on an exterior portion, the second fastener 228 is formed on aninterior portion, and are therefore depicted in phantom. As with thepreviously described embodiments, the second fastener 228 is selectablyengageable with any of the first fasteners 224. The first and secondfasteners 224 and 228 are aligned such that when engaged with oneanother, the longitudinal opening is closed and the distal end portion216 is of a generally frustoconical shape and defines a distal openingthrough which the prosthetic implant is transferred.

Referring to FIG. 6A, a variation on the embodiment of FIG. 6 is shown.In this variant, prosthetic implant device 250 comprises a flexibleelongated member 251 defining a proximal end portion 252 that is shownas a closed end. As with the embodiment shown in FIG. 6 , the distal endportion 254 defines a first longitudinal edge 256 and a secondlongitudinal edge 258. These first and second longitudinal edges definea longitudinal opening 260. A plurality of first fasteners 262 areformed longitudinally adjacent the longitudinal edge 264. A secondfastener 268 is formed longitudinally adjacent the second longitudinaledge 270. In this variant, an implant would be placed within theelongated member prior to forming the distal end opening. Referring toFIGS. 6B-D, implant 272 is inserted into elongated member 251. Thelongitudinal opening 260 is closed by fastening second fastener 268 withone of the plurality of first fasteners 262, and a distal opening 274 isdefined. The elongated member is then positioned such that the implant272 is allowed to slide towards the distal opening 274. The physicianthen transfers the implant through the distal opening and through theincision 276.

The plurality of fasteners depicted in the above embodiments have beenzip-type fasteners. It should be understood, however, that the fastenersmay take other forms. For example, referring to FIG. 7 an embodimentsimilar to that depicted in FIG. 1 is shown. In FIG. 7 , the prostheticimplant device 310 comprises a sheet of material 312 defining a proximalend 314 and the distal end 316. In this preferred embodiment, formedwith a first side portion 318 are a plurality of first fasteners in theform of a series of snap attaching units 322, and formed with a secondside portion 324 is a second fastener in the form of a series of snapclosure units 326. The attaching units and closure units are configuredto be mated to one another. Other snap-type engagements may also beutilized. Whether the first fasteners define the attaching units and thesecond fastener define the closure units or vice-versa is a matter ofdesign choice. Again, the reference to a first fastener or a secondfastener denotes one part of cooperating structures that act to fastenother structures to one another.

Referring to FIG. 8 is another preferred fastener arrangement. In thisembodiment, the prosthetic implant device 410 comprises a sheet ofmaterial 412 defining a proximal end 414 and the distal end 416. Formedwith a first side portion 418 are a plurality of first fasteners in theform of a series of receiving slots 420, and formed with a second sideportion 422 is a second fastener in the form of a series of tabs 424.The slots and tabs are configured to be mated to one another. Other slotand tab type engagements may also be utilized.

Other contemplated fasteners include a hook and loop enclosurearrangement. Such an embodiment is shown in FIG. 9 . Here, theprosthetic implant device 510 comprises a sheet of material 512 defininga proximal end 514 and the distal end 516. In this preferred embodiment,formed with a first side portion 518 are a plurality of first fastenersin the form of a series of either the hook or loop portion of a hook andloop enclosure 522. Formed with a second side portion 524 is a secondfastener in the form of the opposing portion of the hook and loopenclosure 526. The hook and loop portions are configured to be mated toone another. Whether the first fasteners define the hook portion and thesecond fastener define the loop portion or vice-versa is a matter ofdesign choice.

While in the above examples, cooperating structures are used to fastenthe first side portion and the second side portion of a sheet, otherfasteners such as an adhesive may be utilized. The adhesive may be apressure adhesive, or may be an adhesive strip that is exposed byremoving a covering strip. One such embodiment is shown in FIG. 10 .Here, the prosthetic implant device 610 comprises a sheet of material612 defining a proximal end 614 and the distal end 616. In thispreferred embodiment, formed with a first side portion 618 are aplurality of first fasteners in the form of adhesive strips 622 ondesignated portions of the surface of the sheet 612. Formed with asecond side portion 324 is a second fastener in the form of an adhesivestrip 626. The adhesive strips 622 and 626, prior to assembly, mayinclude release strips 623 and 627. It should also be noted, that as analternative to the embodiment in FIG. 10 , that only one adhesive stripmay be required. In such a case, for example, adhesive strips 622 wouldnot be included, and instead, indicators would be marked on the surfaceof the sheet 612 to designate where adhesive strip 626 should beattached for use. It should further be noted that whether the firstfasteners comprise the adhesive and the second fastener define the sheetsurface is a matter of design choice.

Although preferred embodiments of the invention have been describedusing specific terms, devices, and methods, such description is forillustrative purposes only. The words used are words of descriptionrather than of limitation. It is to be understood that changes andvariations may be made by those of ordinary skill in the art withoutdeparting from the spirit or the scope of the present invention which isset forth in the following claims. In addition, it should be understoodthat aspects of the various embodiments may be interchanged, both inwhole, or in part. Therefore, the spirit and scope of the appendedclaims should not be limited to the description of the preferredversions contained therein.

I claim:
 1. A delivery device to facilitate insertion of a breastimplant through a surgical opening, the device comprising: a flexiblesheet having a first edge and second edge transverse from the firstouter edge, a first fastener integrally formed with the flexible sheetalong the first edge, and a plurality of generally parallellongitudinally disposed second fasteners integrally formed with theflexible sheet along the second edge, the first fastener detachablyconnectable with at least one of the second fasteners to form a distalopening at a distal end portion, the distal end portion insertable intothe surgical opening of the patient, and a proximal end portion adaptedto receive the breast implant.
 2. A delivery device to facilitateinsertion of a breast implant through a surgical opening, the devicecomprising: a distal end and a proximal end, the proximal end beingsealed, the distal end opposite the proximal end, the distal end beingnarrower than the proximal end, the distal end adapted to form a distalopening adapted to be inserted into a surgical opening, and a firstlongitudinal edge portion extending from the distal end, a secondlongitudinal edge portion extending from the distal end, the firstlongitudinal edge portion including a first fastener portion, the secondlongitudinal edge including a second fastener portion, the firstfastener portion configured to mechanically engage the second fastener,the first fastener detachably engageable with the second fastenerportion.